IXIARO- japanese encephalitis vaccine, inactivated, adsorbed injection, suspension

Ixiaro by

Drug Labeling and Warnings

Ixiaro by is a Other medication manufactured, distributed, or labeled by Vetter Pharma Fertigung GmbH & Co. KG, Valneva Scotland, Vetter Pharma Fertigung GmbH & Co. KG (Mooswiesen), Vetter Pharma Fertigung GmbH & Co. KG (Schuetzenstrasse), Vetter Pharma Fertigung GmbH & Co. KG (Helmut-Vetter-Strasse), Vetter Pharma Fertigung GmbH & Co. KG (Eisenbahnstrasse). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Valneva - Ixiaro, Carton Label

INGREDIENTS AND APPEARANCE

IXIARO 
japanese encephalitis vaccine, inactivated, adsorbed injection, suspension

Product Information
Product Type	VACCINE	Item Code (Source)	NDC: 62195-051
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: DZ854I04ZE) (JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:DZ854I04ZE)	JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED)	6 ug  in 0.5 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62195-051-10	1 in 1 CARTON
1	NDC: 62195-051-01	0.5 mL in 1 SYRINGE; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA125280	03/30/2009

Labeler - Vetter Pharma Fertigung GmbH & Co. KG (316126754)

Registrant - Valneva Scotland (737272380)

Establishment
Name	Address	ID/FEI	Business Operations
Vetter Pharma Fertigung GmbH & Co. KG (Mooswiesen)		312670654	analysis(62195-051) , pack(62195-051) , label(62195-051)

Establishment
Name	Address	ID/FEI	Business Operations
Vetter Pharma Fertigung GmbH & Co. KG (Schuetzenstrasse)		316126754	manufacture(62195-051) , analysis(62195-051)

Establishment
Name	Address	ID/FEI	Business Operations
Vetter Pharma Fertigung GmbH & Co. KG (Helmut-Vetter-Strasse)		341629292	analysis(62195-051)

Establishment
Name	Address	ID/FEI	Business Operations
Vetter Pharma Fertigung GmbH & Co. KG (Eisenbahnstrasse)		344217323	analysis(62195-051)